Associate Director of Quality Assurance, Operations

Serán is seeking a QA Associate Director,who oversees the day-to-day operations of the Quality Assurance department with oversite of clinical manufacturing and warehouse activities in addition to disposition of raw materials and drug products.  Required attributes include a results-driven and broad-minded quality assurance professional with extensive experience in compliance and regulations, quality systems management, investigations, training and mentoring, client relations, performance management, and change management.  Extensive experience with direct or quality oversite of manufacturing operations is required. The successful candidate will have excellent problem-solving skills and will identify critical quality objectives, develop cross-functional, collaborative, and creative teams, and improve, adapt, and execute practical solutions in competitive and fast-paced environments.

Supervisory Responsibilities Leads and mentors Quality Assurance personnel.

Recruits, interviews, hires and trains new staff.

Oversees daily workflow of the department.

Responsibilities Leads and implements continuous improvement initiatives to reduce risk and improve efficiency for the company’s quality systems and department operations

Management and scheduling of department operations

Oversees and conducts review and approval of Investigations, CAPAs, Complaints, and Change Management

Review and approval of SOPs, batch records, raw material records, and certificates of conformance/compliance

Responsible for Quality oversight of activities involving raw material, drug product manufacturing, packaging, labeling, and warehouse activities

Assures cGMP compliance systems and processes are in place to support raw material and drug product review, release, storage, and shipping

Defines and maintains a strong people management, training, and engagement culture to ensure a high and constantly improving right first-time rate

Supports internal audits, client audits and regulatory inspections

Required Skills and Experience Expert knowledge of GMP guidelines and Quality expectations for preclinical and clinical phase manufacturing operations

In-depth understanding and application of cGMP principles, concepts, practices, and standards

Experience with regulatory inspections by the FDA and EU authorities

Ability to influence diverse stakeholders and drive accountability and decision-making cross functionally

Demonstrated ability to partner with other functional groups to achieve business objectives

Experience organizing and managing group responsibilities while working independently with minimal oversight

Time and project management skills with the ability to multi-task and meet deadlines

Excellent verbal and written communication skills

Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside of the company

Excellent organizational skills and attention to detail

Strong analytical and problem-solving skills

Strong supervisory and leadership skills

Education and Experience Minimum of a bachelor’s degree, preferably in a scientific discipline. An advanced degree is preferred

10+ years previous GMP and Quality experience in the Pharmaceutical industry with quality oversite of Oral Solid Dose manufacturing

Experience with regulatory inspections by the FDA and EU authorities